Christine Garey

• Establishes strong working relationships with vendors through exceptional communication skills
• Manages the preventative maintenance program for all instruments and equipment to ensure it is performed on time and efficiently
• Writes, reviews and edits technical document in accordance with company and regulatory requirements
• Ensures facility and cleanroom management, and oversees the pest control program
• Leads capital expansion projects and manages Engineering deviations, CAPAs, and Change Controls
• Spearheading a project to implement Blue Mountain Regulatory Asset Management (BMRAM) program at the facility
• Manages the Vaisala EMS system
• Troubleshoots equipment and instruments

Oral Solid Dose Client, Supply Chain Project Manager

• Prepared and compiled all documents related to NDA from CMOs
• Contributed to transfer of product from client to new product owner
• Compiled manufacturing batch history report from all CMOs
• Worked on Supply Chain forecasting with all CMOs and new product owner
• Provided answers and acquired documents for audit response

Antibody Development Client, Process Engineer

• Provided manufacturing oversight for downstream antibody production processes
• Supported process validation planning and activities
• Oversaw CMO process development and validation planning activities
• Lead project to revise all CMO downstream manufacturing batch records
• Provided technical guidance and oversight to CMO

Cell Therapy Client, MSAT Process Engineer

• Authored and reviewed quality controlled documents such as Material Specifications, Protocols, Reports, Bill of Materials (BOM), and Site-Specific Process Description (SSPD)
• Streamlined and aligned site documents to ensure continuity and accuracy
• Supported pre-commercial Process Validation (PV) and Engineering studies to ensure adherence to sensitive project timelines
• Contributed to materials Failure Mode and Effects Analysis (mFMEA) for all materials used during manufacturing
• Authored and reviewed Process Validation protocols and reports; collected and analyzed Process Validation data
• Contributed to BLA filing documents and verified all data

• Collaborated with Quality Assurance, Analytical Services, Engineering and Manufacturing to conduct and prepare technical investigations on Production Deviations, including evaluating and troubleshooting manufacturing equipment and process issues, conducting interviews, and collecting and analyzing current and historical data in order to determine root cause and drive process improvement through corrective and preventative actions (CAPA) and effectiveness checks
• Three time recipient of the Endo STAR award for “exceptional and noteworthy contributions to the goals and success of the company” to complete complex investigations and release product
• Prepared experimental batch records and associated protocols for submission to FDA
• Authored change plans and SOPs to ensure continuous improvement in manufacturing
• Founding member of Particle Reduction Team which performed FMEA and drove changes to company policy to minimize particulate matter introduced by equipment, personnel, and raw materials
• Planned, authored, and executed Process Validation (PV) activities for new manufacturing processes

• Maintained a safe and organized laboratory environment by adhering to best practices for chemical handling and waste disposal
• Created SOPs and designed experiments to aid in defining biopharmaceutical manufacturing processes
• Performed chromatography, centrifugation, precipitation, and filtration experiments, and provided detailed technical reports on the analysis and results of these experiments to colleagues
• Conducted research to determine optimal process parameters for biological candidates

• Interpreted instructions and applied engineering principles on assignments, complex features and possible solutions
• Led a historical evaluation of buffer production by applying statistical methods such as control charting, process capability, and matched pairs analysis; authored and published a Technical Report presenting the study’s findings and recommendations , which resulted in increased process control and efficiency, and decreased buffer variability
• Designed and published a study to assess microfiltration process performance
• Supported investigations with data mining, review of operational procedures, and deviation analysis